Scientist II, Analytical Development

About the Role

Responsible for analytical development activities for small molecule drug substances from preclinical through commercial phase. This role is laboratory-focused, requiring deep expertise in analytical chemistry and strong problem-solving skills. With supervision, the scientist II independently provides support to analytical activities including development, execution, validation, transfer and troubleshooting of methods used to control raw materials, in-process, intermediates and final products. While also participate overseeing analytical work performed at external CROs and CDMOs. Conducts work in compliance with cGMP, safety, and regulatory requirements. The position works cross-functionally with teams across CMC, Technical Operations, Quality, Regulatory Affairs, Manufacturing, and external partners to support product development, manufacturing readiness, and regulatory submissions. The role also contributes to overall control strategy development and ensures scientific and technical alignment through all phases of product development.

Your Contributions (include, but are not limited to):

• Responsible for analytical development to support research and development, tech transfer and commercialization of drug substance and drug product processes, as well as oversight of batch testing/release and regulatory document contribution through managerial and individual input
• Provides project management for analytical in support of Chemical and Product Development projects
• Provides analysis and evaluation of material and products at all stages of the development process
• Monitors and evaluates completion of tasks and projects
• Plans and manages projects
• Represents Analytical Chemistry on cross-functional teams
• Maintains accountability for analytical deliverables and progress on R&D and manufacturing plans for all development projects
• Independently designs, plans and executes activities towards the goals of one or more analytical chemistry projects to support pre-clinical through commercial activities
• Supervises laboratory work and/or lab personnel and ensures safe laboratory practices
• Performs analytical development and optimizes methods in support of preclinical through commercialization
• Creates and implements novel ideas and techniques to support analytical activities with Chemical and Product Development
• Provides support for off-site analytical transfers, manufacturing support and interaction with contractors
• Provides input into CMC regulatory documentation and supporting work
• Provides effective supervision of laboratory personnel and guidance for their professional development
• Contributes to development of policies and department strategies
• Builds and enhances internal and external professional relationships
• Effectively see projects to completion
• Understands how to effectively negotiate, persuade, and influence
• Other duties as assigned

Requirements:

• BS/BA degree in chemistry or closely related field and 4 years of experience in the pharmaceutical industry, focusing on analytical chemistry
• Extensive hands-on experience in pharmaceutical analysis, methods development/validation for various active ingredients and/or dosage forms
• MS/MA degree in chemistry or closely related field and 2 years of similar experience noted above OR PhD or equivalent in chemistry or closely related field and some relevant experience; may include postdoc experience
• Demonstrates solid level of understanding project / group goals and methods
• Able to explain the process behind the data and implications of the results
• Strong knowledge of one or more scientific disciplines, becoming expert in one discipline
• Strong knowledge of scientific principles, methods and techniques
• Strong knowledge and demonstrated ability working with a variety of laboratory equipment/tools
• Ability to work as part of a team; may train lower levels
• Ability to leading teams
• Excellent computer skills
• Strong communications, problem-solving, analytical thinking skills
• Detail oriented yet can see broader picture of scientific impact on team
• Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
• Strong project management skills
• Effective report writing and oral presentations skills are required
• Excellent written and verbal communication skills are required
• Must be able to build excellent working relationships & maintain confidentiality regarding intellectual property and proprietary endeavors of the company
• Ability to creatively solve complex problems in a team environment
• Demonstration of cross-functional understanding related to drug development
• A working knowledge of regulatory requirements for drug product commercialization, NDA preparation and cGMP, including knowledge of quality assurance/ quality control practices and issues
• Must have working knowledge of ICH and FDA guidance for analytical method validation, stability, and CTD